capivasertib · Astrazeneca · NDA 218197
Truqap
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Apr 2033
Blocked by patent: US 10039766, US 10039766, US 9487525.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10039766 | use U-3762 | 16 Apr 2033 |
| US 10039766 | use U-4559 | 16 Apr 2033 |
| US 9487525 | substance, product | 16 Apr 2033 |
| US 8101623 | substance, product, use U-3762 | 10 Mar 2030 |
| US 10059714 | substance, product | 10 Oct 2028 |
| US 10654855 | use U-3762 | 10 Oct 2028 |
| US 11236095 | use U-4559 | 10 Oct 2028 |
| US 11760760 | use U-3762 | 10 Oct 2028 |
| US 12252495 | use U-3762 | 10 Oct 2028 |
| US 9492453 | use U-4559 | 10 Oct 2028 |
Exclusivities · 2 unexpired
| I-991 | new indication (3 years) | 12 Jun 2029 |
| NCE | new chemical entity (5 years) | 16 Nov 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218197 · 001 · RLD | tablet, oral | 160MG | 16 Apr 2033 |
| 218197 · 002 · RLD | tablet, oral | 200MG | 16 Apr 2033 |